Sr. Field Clinical Research Associate, Adona Medical

Shifamed LLC; Los Gatos (CA); On-site; USD 130,000 - 150,000; Full time

Job summary

An innovative medical device firm seeks a Sr. Field Clinical Research Associate to manage clinical trials and ensure compliance. This role involves overseeing procedures, supporting investigator training, and analyzing clinical data for regulatory submissions. With a focus on interventional approaches for heart failure, this position offers a dynamic environment where your contributions will directly impact patient care. If you have a strong background in the medical device industry and a passion for improving lives, this is an exciting opportunity to join a forward-thinking team dedicated to innovation in healthcare.

Benefits

Equity options

Comprehensive benefits package

Travel opportunities

Qualifications

• 5+ years in the medical device industry with experience in Class III devices.
• Strong understanding of FDA, ICH GCP, and medical terminology.

Responsibilities

• Manage clinical sites supporting trials in the U.S. and internationally.
• Gather and communicate field data and user feedback.
• Ensure compliance and support trial documentation.

Skills

Cath lab experience

FDA regulations knowledge

Communication skills

Organizational skills

Multitasking skills

Education

Bachelor's degree in a related field

Job description

Our team shares a passion for developing innovative medical technologies that improve patients’ lives. If you are seeking a dynamic environment where you can make a real impact, Shifamed is a good fit for you.

Position: Sr. Field Clinical Research Associate, Adona Medical

Location: Los Gatos, CA

Job Id: 581

# of Openings: 0

Adona Medical, a Shifamed Portfolio Company, is focused on innovating interventional approaches for heart failure, a complex and progressive condition impacting approximately 6.5 million patients in the U.S. and up to 26 million globally. More about Adona Medical can be found at https://www.adonamed.com/.

About Shifamed

Founded in 2009 by Amr Salahieh, Shifamed LLC is a private medical device innovation hub developing novel products in cardiology and ophthalmology.

Description

The Field Clinical Research Associate manages clinical sites supporting trials in the U.S. and internationally, overseeing procedures, site start-up, device training, and logistics. Responsibilities include ensuring compliance, supporting site and patient management, and providing feedback to R&D teams.

Responsibilities, Skills & Hands-On Experience

• Understand therapeutic areas and study protocols.
• Support investigator training and device installation.
• Assist in procedures and ensure protocol adherence.
• Gather and communicate field data and user feedback.
• Participate in site initiation and training.
• Prepare sites for inspections.
• Support trial documentation and adverse event reporting.
• Identify user needs to support marketing and initiatives.
• Analyze clinical data for regulatory submissions.
• Ensure SOP compliance and GCP adherence.
• Resolve obstacles in study execution and recruitment.
• Minimum 3 years’ cath lab experience with high-risk cardiovascular devices.
• Experience in FDA-regulated environments, preferably with Class III devices.
• Excellent communication skills.
• Willingness to travel, including international travel.

Education & Work Experience

• Bachelor’s degree in a related field with 5+ years in the medical device industry.
• Experience with IDE studies involving Class III cardiovascular devices.
• Knowledge of FDA, ICH GCP, and medical terminology.
• Ability to develop strong research site relationships.
• Willingness to travel extensively (up to 80%).
• Strong communication, organizational, and multitasking skills.

The salary range for this full-time role is $130,000 to $150,000, plus equity and benefits. Salary will be based on experience and qualifications.

Note: Shifamed does not conduct interviews via mobile web chat and does not accept unsolicited resumes without prior approval. For more information, contact [e-mail].